Brexit-related guidance for companies

The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.

This aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines in the EU for the benefit of patients, based on the assumption that the UK will become a third country as of 30 March 2019.

Stakeholder meetings

EMA has published reports with updates from the Agency and EU industry associations on their preparations for Brexit and information on planned stakeholder engagement activities from the Agency's meetings with industry stakeholders:

Industry survey(updated)

EMA carried out a Brexit-preparedness survey in 2018 to gather information from marketing authorisation holders for centrally authorised products on their plans to update their marketing authorisations in preparation for Brexit.

The main objective was to to gather information on the timelines for submission of the necessary regulatory changes and identify any centrally authorised products potentially at risk of supply shortages.

EMA sent the survey to marketing authorisation holders of 694 centrally authorised products (661 human and 33 veterinary products) either located in the UK or with an important step in their regulatory processes in the UK, such as quality control, batch release and/or import manufacturing sites, QPPV and pharmacovigilance system master file (PSMF).

According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.